Vasculitis Remission Predicts Long-Term Risks

Remission at months 3 and 6 protected against death and end-stage renal failure

Early and sustained remission may be a useful predictor of long-term mortality and end-stage renal failure (ESRF) among patients with antineutrophil cytoplasm antibody (ANCA)-associated vasculitis (AAV), a study by the European Vasculitis Society suggested.

Among patients with AAV included in four inception trials from 1995 to 2002, outcomes at 6 months were retrospectively categorized as sustained remission (remission by month 3 and sustained at month 6), late remission (remission after month 3 and by month 6), relapsing disease (remission by month 3 but relapse by month 6), and refractory disease (no remission by month 6), according to Seerapani Gopaluni, MBBS, of the University of Cambridge in England, and colleagues.

The Cox proportional hazards model compared the likelihood of reaching the composite endpoint of death or ESRF for late remission, relapsing disease, and refractory disease versus sustained remission, as follows:

Late remission, HR 2.94 (95% CI 1.1-7.85, P=0.031)

Relapsing disease, HR 8.21 (95% CI 2.73-24.65, P=0.001)

Refractory disease (HR 4.89, 95% CI 1.96-12.18, P=0.001)

This indicated that only patients who were categorized as having sustained remission at 6 months had no increased risk of the composite endpoint, the researchers reported online in Arthritis & Rheumatology.

ANCA-associated vasculitis is characterized by necrotizing inflammation of the small blood vessels and is lethal if untreated. The two primary forms are granulomatosis with polyangiitis and microscopic polyangiitis.

Clinical trials in the past have most often used remission or relapse as outcome measures, but there has been no consensus as to what the optimal endpoints for clinical studies should be. The current study has examined the possibility of using early treatment response as an endpoint, which would provide an earlier outcome measure that could be used in clinical trials.

Disease activity at months 3 and 6 was assessed on the Birmingham Vasculitis Activity Score, with remission defined as a score of zero. The analysis was based on 354 patients.

At months 3 and 6, respectively, 84.8% and 89.8% of patients were in remission. By month 6, 79.9% were in sustained remission, 10% were in late remission, 5.2% had relapsing disease, and 5.2% had refractory disease.

During a median follow-up of 5.7 years, 18.6% of patients died. This included 16.9% of the sustained-remission group, 20% of the late-remission group, 27.8% of the relapsed-disease group, and 33.3% of the refractory group.

A total of 10.4% of patients developed ESRF, which included 10.6% of the sustained-remission group, none in the late-remission group, 11.1% of the relapsed-disease group, and 16.6% of the refractory group.

The composite endpoint of death or ESRF was seen in 23.2% of patients, including 22.4% of the sustained-remission group, 15.6% of the late-remission group, 27.7% of the relapsed-disease group, and 38.8% of the refractory group. On the regression analysis, factors that predicted this endpoint along with disease status at 6 months were age (HR 1.02, 95% CI 1-1.05, P=0.012) and estimated glomerular filtration rate (HR 0.94, 95% CI 0.92-0.95, P=0.001).

"This study establishes the fact that 3 and 6 months' data can be used as a surrogate for long-term mortality and ESRF. This emphasizes the need for faster-acting therapies," Gopaluni and co-authors wrote, noting that among the newer therapies being investigated are plasma exchange and the C5a receptor inhibitor avacopan.

The study was limited by its retrospective design, the research team said.

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